Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice
PLOS: January 14, 2014 Three basic principles are key in assessing the ethics of any research conducted on humans: respect for persons (or autonomy), beneficence, and justice [1]. Respect for persons entails individuals being afforded the right to decide what should happen to them; this principle is fulfilled through a valid informed consent process. Research participants should […]
Non-publication of large randomized clinical trials: cross sectional analysis
BMJ: 10/29/13 Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. Design Cross sectional analysis Setting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial […]
FDA Helping to Advance Treatments Tailored to You
FDA: 10/29/13 Personalized medicine is the tailoring of a medical treatment to the individual characteristics, needs and preferences of a patient. Many recent advances involve using a patient’s genetic information to guide his or her treatment. Developing a truly personalized approach to patient care will require fundamental advances in the understanding of the biological, anatomical and […]
The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice
Health and Quality of Life Outcomes: 10/29/13 To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians […]
Recruiting clinical personnel as research participants: a framework for assessing feasibility
BMC: October 24, 2013 Increasing numbers of research studies test interventions for clinicians in addition to or instead of interventions for patients. Although previous studies have enumerated barriers to patient enrolment in clinical trials, corresponding barriers have not been identified for enrollingclinicians as subjects. We propose a framework of metrics for evidence-based estimation of time and […]
Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration The Class of 2008
JAMA Intern Med. Published online October 28, 2013 Importance The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. Objective To inform the debate about appropriate standards, we studied the development […]
Participating in Clinical Trials is “Paying it Forward”
FOXFEED BLOG: October 25, 2013 Twice a year, Rob Sollenberger, a retired U.S. Navy Captain, flies from the Rocky Mountains to Johns Hopkins University in Baltimore as a participant in theParkinson’s Progression Markers Initiative (PPMI). Sponsored by The Michael J. Fox Foundation, PPMI seeks to identify biomarkers, or indicators of Parkinson’s disease (PD), that could enable […]
